Collaborate2Lose: Involving Support Persons in Weight Management

VA Office of Research and Development

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Veteran-only intervention; Behavioral: Dyadic intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05448313

IIR 21-101

Details and patient eligibility

About

This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.

Full description

Dyads comprising a Veteran with obesity and a cohabitating adult will be randomized to participate in a weight management program by the Veteran alone or with their support person. The program will be delivered by research staff using a secure video platform. Outcomes will be assessed remotely at baseline and weeks 24, 48, and 72, with 72 weeks as the primary endpoint.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient inclusion criteria

• aged 18 years or older
• BMI >= 30 kg/m2
• at least one visit with a VA primary care provider within the past year
• weight <=420 lb due to study scale limits
• have been cohabitating and have daily contact over the past 6 months with an adult who can provide support (e.g., spouse/domestic partner, sibling, adult child, friend, family member) for the next 18 months
• desire to lose weight
• able to stand for weight measurements without assistance
• < 2 errors on a validated 6-item cognitive screener
• ability to speak English
• agrees to attend visits per protocol
• individual email-address
• access to hardware and internet connection to enable participation with approved virtual platform Partner inclusion criteria
• aged 18 years or older
• willing to participate
• < 2 errors on a validated 6-item cognitive screener
• ability to speak English
• individual email address

Exclusion criteria

Patient exclusion criteria

• active dementia or substance abuse
• history of bariatric surgery or planning to have bariatric surgery in the next 18 months
• pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
• weight loss >= 10 lb in the month prior to screening
• living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
• unable to control what food is purchased and / or served
• impaired hearing
• current use of weight loss medications
• chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization)
• participation in VA MOVE! weight management program in the past 6 months
• current participation in a research or clinical program focusing on lifestyle change
• vomits once or more per week Partner exclusion criteria
• BMI < 18.5 kg/m2
• active dementia or substance abuse
• impaired hearing
• chronic or unstable illness that would impair their ability to provide support
• living in a facility such as a nursing home, skilled nursing facility, or assisted living facility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Dyadic intervention

Experimental group

Description:

Veterans and their support person will participate in MOVE!

Treatment:

Behavioral: Dyadic intervention

Veteran-only intervention

Active Comparator group

Description:

Veterans will participate in MOVE! alone

Treatment:

Behavioral: Veteran-only intervention